Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment

Summary

The scientific goals of the project are:

1. The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to:

* usual care (i.e. superiority of the eHealth self-management support program) and
* a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program)

on pain-related disability (measured with the Pain Disability Index).
2. The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including:

* Other dimensions of pain
* Health-related quality of life
* Physical functioning, including physical activity levels
* Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence
* Participation in society, including return to work
* Healthcare-related costs for the patient and society
3. The tertiary scientific objectives of this study are

* to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets.
* To examine the implementation process, mechanisms of impact and contextual factors.

Conditions

• Breast Cancer

Interventions

BEHAVIORAL

eHealth self-management support program

This web-based eHealth program consists of two parts. First participants will complete a pain science education program. After being primed in the educational program, barriers for a physically active lifestyle should be removed and participants should be able to apply the learned information in the second part. The second part of the self-management support program consists of daily activity planning and strategies to promote an active lifestyle. The eHealth program will be accessible from any digital device (laptop, tablet, smartphone) after receiving a personal login code provided by the researcher. Participants go through the eHealth program independently at their own pace. It is recommended to do this in 8-12 weeks.

BEHAVIORAL

Face-to-face rehabilitation program

The face-to-face rehabilitation program combines pain science education with an active behavioral approach. First, 2-3 individual face-to-face sessions are organized with a physical therapist to provide pain science education. The content of this pain science education program is the same as for the eHealth program. Similar as in the eHealth program, this education intervention includes advice for activity management, while experiencing pain and other symptoms, in order to remove barriers for an active lifestyle. The educational information will be presented verbally and written. After the education, the physical therapist will discuss proper goal setting with the patient to reach an active lifestyle and will coach the participant to reach these goals with maximum 6 face-to-face sessions. It is recommend to organise the in total 9 face-to-face sessions within a periode of 8-12 weeks.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• University Ghent

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• University Hospital, Antwerp

  collaborator OTHER

• Universiteit Antwerpen

  lead OTHER

Principal Investigators

• An De Groef, PhD · Universiteit Antwerpen

• Nele Devoogdt, PhD · KU Leuven

• Geert Crombez, PhD · UGent

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-26

Primary Completion

2028-06-30

Completion

2029-01-31

Countries

• Belgium

Study Locations